Embodiments described herein relate generally to devices, systems and methods for monitoring patient adherence to treatment regimens, and particularly to such a device that enhances patient adherence to a prescription medication regimen.
Adherence is commonly defined as the extent to which a patient complies with a clinician's recommended treatment regimen (e.g., by taking prescribed medications). Medication non-adherence contributes to 125,000 deaths annually in the United States, leads to 10-25% of hospital and nursing home admissions, and costs $300 billion annually in excess medical expenses.
Hospital costs due to patient non-adherence are estimated at $8.5 billion annually. With the recent intensive movement to cost sharing (e.g., Accountable Care Organizations), hospital systems face severe financial penalties for early re-hospitalizations based on medication non-adherence following discharge. Studies show that approximately 50% of the 2 billion prescriptions filled each year are not taken as prescribed. (J. A. Cramer et al., “How Often Is Medication Taken as Prescribed? A Novel Assessment Technique,” Journal of the American Medical Association (9 Jun. 1989)). Low adherence to prescribed treatments has been shown to undermine treatment benefits. (Sackett D L, Snow J C. The magnitude of adherence and non-adherence. In: Haynes R B, Taylor D W, Sackett D L, eds. Adherence in Health Care. Baltimore, Md.: Johns Hopkins University Press; 1979:11-22).
Another area where patient adherence is particularly essential is in drug clinical trials, because non-adherence can lead to erroneous data that can skew the results of the clinical trial. The motivation of clinical trial subjects to adhere to the prescribed drug regimen can be variable leading to a higher rate of non-adherence. Since the cost of a single drug trial is generally in the range of billions of dollars, it is imperative to monitor and ensure adherence of the study subjects to the prescribed regimen.
Several studies have found that although systems and methods of enhancing compliance are available, such systems and methods are labor intensive and complex, thereby complicating dissemination and general usability. Thus, a majority of findings indicate that the full benefit of medications being prescribed is not being achieved due to low adherence levels (Haynes et al. 2002).
While the medication non-adherence problem has been clearly identified, the current monitoring/reminding systems do not provide a comprehensive solution that scales and addresses the multiple challenges to medication adherence. Thus, a need exists for improved and simplified devices, systems, and methods for monitoring and improving patient adherence to treatment regimens.